EU Regulation 10/2011

EU Regulation 10/2011 concerns plastic materials, ensuring that they are fit-for-purpose for use in food contact applications. Our experts can help you gain regulatory approval with consultative guidance, comprehensive analysis, and support with documentation submission.

EU Regulation 10/2011 is a specific measure within Regulation (EC) 1935/2004 – the main piece of legislation covering food contact materials intended for sale within the European Union.

This Regulation covers plastics materials and articles which are:

  • Intended to come into contact with food
  • Already in contact with food
  • Reasonably expected to come into contact with food

The regulation applies to all materials which contain plastics – whether exclusively or as part of a multi-layer structure. The regulation also applies to plastic materials covered in a coating, and plastic layers which form gaskets in caps and closures.

The directive contains the following requirements:

  • A limit on the total amount of material that can be transferred to food from plastic packaging. This is known as the overall migration limit.
  • A positive list for monomers which can be used in Food Contact plastics. Some of these monomers have their own specific migration limits.
  • A partial positive list for additives which can be used in Food Contact plastics. Some of these have their own specific migration limits.

Proving adherence to EU Regulation 10/2011 is a mandatory requirement for plastic food contact materials. The responsibility for compliance lies with the packaging manufacturer, and any material changes should be re-analysed to demonstrate continued safety.

Expert support for regulatory compliance

We can help you demonstrate compliance with these regulations through appropriate testing, and provide expert guidance in submitting your documentation to the relevant regulatory bodies.